NHS Lothian- University Hospitals Division

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1 Pre-transplant ograph or Consultant Surgeon: Transplant Nurse: Consultant Diabetologist: Diabetes Specialist Nurse: Dietitian: NHS Lothian- University Hospitals Division Consultant Radiologist: Recipient CMV Status EBV Status Donor CMV Status EBV Status 1. Admit under Transplant team (Ward 206 Transplant, RIE) 2. Diagnosis: Type 1 diabetes for islet transplantation 3. Transplant consent form to be completed 4. Obtain hospital notes from transplant office, notes stored in the transplant filing cabinets 5. Record: Height, weight, waist circumference on admission HR, BP lying and standing, Temp and oxygen saturations 4 hourly Blood glucose monitoring hourly 6. Please inform Diabetes Registrar (on call up to 8pm), Dr Shareen Forbes, Islet Transplant Diabetologist, Debbie Anderson, Diabetes Dietitian on ext and Diabetes Specialist Nurse on ext or bleep 5955 of admission. 7. Note patient will be contacted the night before admission. The regimen will be individualised to the patient and must be discussed with the Diabetes team. - If on multiple dose insulin (MDI) regimen and procedure is planned for the morning: usual dose of long acting insulin (eg. Lantus or Levemir) at night, and omit breakfast and omit morning short acting insulin. If on long acting insulin in the morning this may be taken. - If on MDI regimen and procedure is planned for the afternoon (including late afternoon): Usual short acting insulin with breakfast before 07.30h and omit lunch and omit usual short acting lunchtime insulin. If on long acting insulin in the morning this may be taken. - If on Continuous Subcutaneous Insulin Infusion (CSII)and procedure planned for morning: omit breakfast but continue on pump at usual basal rate until two hours pre-procedure - If on CSII and procedure planned for afternoon: have bolus of insulin with breakfast before 7.30 am then continue on normal/usual basal rate until two hours pre-procedure. If procedure planned for late afternoon then theoretically light lunch may be taken. 8. When patient admitted, obtain blood glucose monitoring probe (Guardian) from Diabetes Specialist Nurse / Dietitian who will attach to patient. University Hospitals Division: Islet Transplant Management. Version 04/02//2014; Dr Shareen Forbes 1

2 Pre-transplant ograph or 9. Clear fluids may be taken orally up to two hours pre-procedure. Nil by mouth for at least 2 hours pre procedure. At this time convert to intravenous insulin with intravenous fluids. Place 18 Fg IV cannula in large arm vein. 10. Send blood to lab for: Full blood count and differential* Platelets* * = urgent Result required prior to procedure INR* PT, APTT, APTT Ratio* HbA1c Electrolytes, urea, creatinine* Liver function tests* Serum pregnancy test in fertile females* Serum CMV IgG, EBV, HBcAb, HBsAg, Hep C, HIV HLA type and Lymphocytotoxic Cross-match (10ml EDTA and 10ml clotted sample) negative cross-match result must be available pre-transplant unless vxm and retrospective cross-match specifically agreed by the H&I team. ABO Group and X match 2 units Blood culture x 2 C&S and fungi, if pt in hospital in previous week 11. Send urine for: MSU for C&S and fungi Urinalysis (Inform Diabetes Team if > ++ ketouria) 12. MRSA screen 13. Send sputum for C&S and fungi 14. Urgent CXR if not done in last 3 months and ECG 15. STOP metformin if patient using it on admission and for 48 hours post procedure 16. Telephone to inform catering supervisor of need to issue Islet Transplant Carbohydrate Restricted Menu. Contact and liaise with Debbie Anderson, Diabetes Dietitian on ext and inform ward Dietitian of patient admission 17. Intravenous insulin regime to be prescribed by Diabetes Registrar. (See Healthcare A Z section of the NHS Lothian Intranet: Healthcare Healthcare a-z D Diabetes Metabolic unit handbook Diabetes protocols) Note patient s usual total dose of insulin over 24 hours: Adjust insulin regimen to achieve blood glucose 4 7 mmol/l 50 units Human Actrapid made up to 50 mls 0.9% sodium chloride (= 1 unit/ml) Check blood glucose at least hourly but every 15 minutes if glucose <4mmol/L until glucose >4mmol/L: If glucose <4mmol/L, switch insulin off, administer 100ml 10% dextrose stat repeat every 15 mins until BM>4mmol/L Note: Intravenous insulin has a half-life of 2.5 minutes, so if stopped for any length of time, hyperglycemia will occur. Intravenous Fluids Please prescribe all fluids on patient s drug chart. The fluids below are a guide only. Discuss fluids and infusion rate with Diabetologist Commence 5% glucose 500ml infusion with 20 mmol of KCl at 50ml/hr (or 100 ml/hr) usually alternating with 5% glucose 500ml infusion at 50ml/hr In parallel administer mixed bag of 0.45% saline/ 5% glucose 500ml at50ml/hr Individualise infusion rate for islets after kidney to keep patient hydrated while nil by mouth Note: If the blood glucose 14mmol/l, the glucose infusion should be deferred until the intravenous insulin has lowered the blood glucose to <14 mmol/l. In this case it may be appropriate to use 0.9% sodium chloride Note: The insulin and glucose infusions are given through the same IV cannula, with a non-returning valve University Hospitals Division: Islet Transplant Management. Version 04/02//2014; Dr Shareen Forbes 2

3 NHS LOTHIAN ADULT INTRAVENOUS INSULIN PRESCRIBING CHART.... ograph or Insulin infusions are continuous and made up of: 50 units soluble insulin (Actrapid) in 50ml of 0.9% Sodium Chloride so that 1ml = 1 unit. Commence 5% glucose 500ml infusion with 20 mmol of KCl at 50ml/hr (or 100 ml/hr). Alternate with 5% glucose 500ml infusion at 50ml/hr. Suggested scale Adjusted scale 1 Adjusted scale 2 Blood Glucose Rate (units/hr) Blood Glucose Rate (units/hr) Blood Glucose Rate (units/hr) <4 Nil Doctor s sign & print Doctor s sign & print Doctor s sign & print Check capillary blood glucose hourly while on IV insulin Time (24hour clock) Blood Glucose (mmol/l) Insulin rate (units/hr) Signature Time (24hour clock) Blood Glucose (mmol/l) Insulin rate (units/hr) Signature MONITORING CHART University Hospitals Division: Islet Transplant Management. Version 04/02//2014; Dr Shareen Forbes 3

4 Pre-transplant ograph or For ISLET ALONE For patient having first transplant (please prescribe on patient Kardex): 1. Omeprazole 40mg PO, 4 hours before transplant 2. Piperacillin/Tazobactam4.5 gm IV 8hrly for 24 hours (3 doses). Start 1-2 hours pre-transplant. If allergic to penicillin give Vancomycin 1g IV in 250ml sodium chloride 0.9% over 2 hours (one dose only, adjust dose if renal impairment) and Ciprofloxacin 400mg IV over one hour (12hrly for 24 hours (2 doses)). 3. Paracetamol 1g PO, 30 mins before Alemtuzumab (MabCampath) 4. Chlorpheniramine 10mg IV, 30 mins before Alemtuzumab (MabCampath) 5. Hydrocortisone 100mg IV, 30 mins before Alemtuzumab (MabCampath) 6. Alemtuzumab (MabCampath)* 30mg SC (stored in transplant fridge, 30mg/1ml vial in solution draw up 1ml into syringe) and give SC into thighs, arms or buttocks over 1-2 minutes, (Pharmacist Bleep 2294 / 8006). Alemtuzmab to be given on ward prior to going down to radiology for islet cell transplant. Transplant Co-ordinator will advise once final cell count has been confirmed. All patients to go down with 5% glucose infusion. Additional 20% glucose must be taken down to radiology for treatment of hypoglycaemia. * For second and third transplants, Alemtuzumab only to be prescribed on Transplant Surgeon s instructions. See post transplant orders for subsequent Prograf (Tacrolimus) and Mycophenolate Mofetil (MMF) doses. Aim for Tacrolimus trough level 8-10 µg/l. For ISLET AFTER KIDNEY For patient with previous transplant, still on full immunosuppression including Prograf (Tacrolimus) aim for Tacrolimus trough level 8-10 µg/l. If in target range give as per usual dose BD* 1. Omeprazole 40mg PO, 4 hours before transplant 2. Piperacillin/Tazobactam 4.5 gm IV 8hrly for 24 hours (3 doses). Start 1-2 hours pre-transplant. If allergic to penicillin give Vancomycin 1g IV in 250ml sodium chloride 0.9% over 2 hours (one dose only, adjust dose if renal impairment) and Ciprofloxacin 400mg IV over one hour (12hrly for 24 hours (2 doses)). 3. Paracetamol 1g PO, 30 mins before Alemtuzumab (MabCampath) 4. Chlorpheniramine 10mg IV, 30 mins before Alemtuzumab (MabCampath) 5. Hydrocortisone 100mg IV, 30 mins before Alemtuzumab (MabCampath) 6. Alemtuzumab (MabCampath)* 30mg SC (stored in Transplant fridge, 30mg/1ml vial in solution draw up 1ml into syringe in interventional radiology suite) and give SC into thighs, arms or buttocks over 1-2 minutes, (Pharmacist Bleep 2294 / 8006) Alemtuzmab to be given on ward prior to going down to radiology for islet cell transplant. Transplant Co-ordinator will advise once final cell count has been confirmed. 7. Mycophenolate Mofetil 500mg BD (10.00 and 22.00) unless other specific regimen appropriate. To discuss with Transplant Team. 8. Prograf (Tacrolimus) (check trough level (target 8-10ug/L) *if in target, usual dose of Prograf (Tacrolimus) BD (10.00 and 22.00) - unless other specific regimen appropriate. To discuss with Transplant Team. All patients to go down with 5% glucose infusion. * For second and third transplants, Alemtuzumab only to be prescribed on Transplant Surgeon s instructions. If blood products are required IRRADIATED blood only to be given post transplant. University Hospitals Division: Islet Transplant Management. Version 04/02/2014; Dr Shareen Forbes 4

5 Pre-transplant ograph or FOR ISLET AFTER KIDNEY: A different regimen may be required from standard CAMPATH/ Prograf / MMF. Discuss with transplant team. 18. Analgesia (To be prescribed on patient s Kardex) Paracetamol 1g QDS Additional analgesic requirements to be prescribed by Transplant Team Ondansetron 4 mgs QDS/Cyclizine 50 mgs TDS depending on patient s analgesic requirements. 19. Radiology Radiologist to prepare, prescribe and administer sedation. Surgeon to prepare and add heparin to islet bags prior to infusion (usually 35 units per kg body weight, (intraportal), into bag containing islets (not the rinse solutions) University Hospitals Division: Islet Transplant Management. Version 04/02/2014; Dr Shareen Forbes 5

6 Islet infusion summary form (to be completed in radiology and inserted into the patient records) / / Radiologist: Surgeon/physician: Islet lab sign off: Time of islet infusion Time of X clamp (24 hr clock): Total ischaemic time (X clamp ) hrs Donor details: Transplant Protocol: Blood group: Transplant #: 1 st 2 nd 3 rd Recipient weight: kg Blood group Packed volume (Bag with purified islets) *Heparin added to bag prior to infusion Total volume Residual volume (not infused) TOTAL islet packed cell volume infused Wash medium (total volume infused) mls units (1000 units/ml) mls mls mls Must be less than 10 mls mls *State heparin dose: usually 35units per kg only in bag containing islets (not the rinse solutions): Portal access: Routine / complicated: Catheter tip (main pv): Y / N Catheter size used (4 Fr): Other comments: Signed: University Hospitals Division: Islet Transplant Management. Version 04/02/2014; Dr Shareen Forbes 6

7 Post-transplant ograph or On return from radiology 1. OBSERVATIONS: Temperature, heart rate, blood pressure, oxygen saturations, respirations every 15 minutes x 1 hours; then every 30 minutes x 2 hours; then every 1 hour x4 hours. Call transplant team: ( > greater than, < less than ) Temp > 38º C. HR > 100 or < 60. Systolic BP > 160 or < 100 mmhg. Diastolic BP > 100 or < 60 mmhg. 2. ACTIVITY: Bed rest for 4 hours lying on right side, then activity as tolerated. 3. STAT BLOODS: Full clotting screen. FBC including, WBC and differential. 4. DOPPLER USS: Ensure Doppler USS of liver has been arranged for within 24 hours post-procedure 5. DIET: Nil By Mouth for 4 hours post-transplant, then clear fluids. If patient tolerating clear fluids they can choose from Islet Transplant Carbohydrate Restricted Menu which should have already been arranged by, Diabetes Dietitian (ext 21460)., If there are any catering queries contact the catering supervisor (ext 24242) and liaise with Diabetes Dietitian (ext 21460). Note: While Nil By Mouth patient must continue on intravenous insulin treatment with intravenous fluids as indicated overleaf. 6. INTRAVENOUS THERAPY: Insulin Management: Please contact on-call Diabetes registrar (Bleep #6800) (Mon Friday ; Sat/Sun ) or Diabetes team with any concerns. Target glucose 4 7 mmol/l Intention: avoid stimulation of beta cells Note: the islet solution contains free insulin from disrupted islets CHECK Capillary glucose on patient s return to ward, then hourly for the first 48 hours. If patient fitted with continuous glucose monitor, capillary glucose readings MUST still be taken for verification of blood glucose concentrations. After 48 hours, check capillary glucose pre meals, two hours post meals and at bed time. University Hospitals Division: Islet Transplant Management. Version 04/02/2014; Dr Shareen Forbes 7

8 Post-transplant ograph or Insulin Infusion Instructions for First 4 Hours or until eating (GOAL: Glucose between 4 7 mmol/l). 50 units Human Actrapid made up to 50 mls 0.9% sodium chloride (= 1 unit/ml) see adult intravenous insulin prescribing chart page 3. Continue 0.45% sodium chloride / 5% glucose 500ml infusion as previously until drinking Continue 5% glucose 500ml infusion with 20 mmol of KCl at 50ml/hr or 100 ml/hr (Discuss with diabetologist, appropriate glucose concentration and rate) for first 8 hours, or until eating, whichever is sooner Check blood glucose hourly but every 15 minutes if glucose <4mmol/L* until glucose >4mmol/L *If glucose <4mmol/L, switch insulin off, administer 100ml 10% dextrose stat repeat every 15 mins until blood glucose >4mmol/L. If patient is NOT Nil By Mouth give 5 dextrose tablets or 100ml lucozade. Note: Intravenous insulin has a half-life of 2.5 minutes, so if stopped for any length of time, hyperglycemia will occur. Note: If the blood glucose 14mmol/l, the glucose infusion should be deferred until the intravenous insulin has lowered the blood glucose to <14 mmol/l. Note: The insulin and glucose infusions are given through the same IV cannula, with a non-returning valve. University Hospitals Division: Islet Transplant Management. Version 04/02/2014; Dr Shareen Forbes 8

9 NHS LOTHIAN ADULT INTRAVENOUS INSULIN PRESCRIBING CHART POST TRANSPLANT.... ograph or Insulin infusions are continuous and made up of: 50 units soluble insulin (Actrapid) in 50ml of 0.9% Sodium Chloride so that 1ml = 1 unit. Commence 5% glucose 500ml infusion with 20 mmol of KCl at 50ml/hr (or 100 ml/hr). Alternate with 5% glucose 500ml infusion at 50ml/hr. Suggested scale Adjusted scale 1 Adjusted scale 2 Blood Glucose Rate (units/hr) Blood Glucose Rate (units/hr) Blood Glucose Rate (units/hr) <4 Nil Doctor s sign & print Doctor s sign & print Doctor s sign & print Check capillary blood glucose hourly while on IV insulin Time (24hour clock) Blood Glucose (mmol/l) Insulin rate (units/hr) Signature Time (24hour clock) Blood Glucose (mmol/l) Insulin rate (units/hr) Signature MONITORING CHART University Hospitals Division: Islet Transplant Management. Version 04/02/2014; Dr Shareen Forbes 9

10 Post-transplant ograph or Subcutaneous Insulin Instructions ONCE EATING (GOAL: Glucose between 4 7 mmol/l): Continue hourly blood glucose monitoring and intravenous insulin scale until reviewed by Diabetes Team. Once eating,discontinue intravenous glucose Re-commence basal insulin, or if patient on a pump, CSII may be restarted. Administer subcutaneous insulin based on pre-meal capillary glucose readings and carbohydrate load (approx.30-35g carbohydrate or snack of 15G or 0G carbohydrate). Note: patients will have a particular ratio of amount of insulin required per 10G carbohydrate (please discuss with Debbie Anderson, Dietitian or Janet Barclay, Diabetes Specialist Nurse). Note: The amount of insulin required for a carbohydrate restricted meal is individualised to the patient, reflecting amount needed to cover amount of carbohydrate as well as the amount needed to correct the glucose reading to a target value of 6 mmol/l If patient was on metformin do not start until at least 48 hours post-procedure. Ensure egfr>40 mmol/l, serum creatinine<150umol/l. 7. OTHER MEDICATIONS: (To prescribe on drug Kardex) 1. 2 further doses of Piperacillin/Tazobactam4.5 g IV (8 hours apart); If allergic to penicillin give x1 further dose of Ciprofloxacin 400mg IV over one hour (12 hours apart from first dose) 2. Omeprazole 40mg PO OD to continue post discharge 3. Mycophenolate Mofetil (MMF) 500mg PO BD at 1000 and 2200 hours (or alternative dose / immunosuppression if appropriate) 4. Tacrolimus (Prograf) 0.05mg/kg PO BD at 1000 and 2200 hours; or usual dose if already on drug (or alternative Dose / immunosuppression if appropriate) 5. Co-Trimoxazole 480mg PO OD for 6 months for PCP prophylaxis. If patient allergic to Co-Trimoxazole Dapsone 100mg PO OD is second line treatment. 6. Unfractionated Heparin sodium (minihep) 5000 units sc BD. Withhold if APTR >1.5. One day before discharge convert to Dalteparin 2,500 units sc once daily. Continue heparin sc for total of 7 days. Consider continuing unfractionated heparin post-discharge if CrCl<30ml/min University Hospitals Division: Islet Transplant Management. Version 04/02/2014; Dr Shareen Forbes 10

11 Post-transplant ograph or 7. Valganciclovir 900 mg PO OD for 6 months for CMV prophylaxis. For all transplant recipients except CMV ve recipients of CMV ve donors. Dose as per creatinine clearance (see table below) Creatinine clearance (ml/min) Prophylactic dose >60 900mg OD 40 to mg OD 25 to mg every 2 days 10 to mg twice weekly 8. Paracetamol 1g PO QDS 9. Additional analgesic requirements to be prescribed by Transplant Team 10. Ondansetron 4mg/Cyclizine 50mg TDS 11. Glucagon 1 mg IM PRN if blood glucose < 2.8 mmol/l and patient cannot be treated orally 12. TB prophylaxis only for those with a history of TB, or born in the Asian/African continent: isoniazid PO 300mg OD and pyridoxine PO 10mg OD (prophylaxis of isoniazid induced neuropathy) 8. LABORATORY / DIAGNOSTIC STUDIES: 4 hours post transplant: FBC including WBC and differential.coagulation screen. Routine Studies (Routine Requisition): 1. DAILY: FBC including WBC with differential, coagulation screen, glucose (fasting), c-peptide (only if off insulin), insulin (if off insulin). 2. ALTERNATE DAYS: trough Tacrolimus level (Monday, Wednesday, Friday) On discharge, patient may need to attend the ward for bloods prior to the Monday clinic, depending upon day of discharge. Radiology: EARLY AM post-procedure and on Day 7 +/- at the Monday am Doppler ultrasound clinic University Hospitals Division: Islet Transplant Management. Version 04/02/2014; Dr Shareen Forbes 11

12 Post-transplant ograph or 9. BLOOD PRODUCTS If blood products are required then the patient should be given IRRADIATED BLOOD only post Alemtuzumab administration. This procedure should be followed for subsequent islet cell transplants. 10. DISCHARGE On discharge the patient will be provided with a sheet containing: 1. Subcutaneous insulin regimen 2. Medication booklet including immunosuppression schedule. See over-leaf for table of drugs. Note TOTAL duration of drug treatment is shown. 3. Follow up appointments for the Monday transplant clinic and other studies (to liaise with Kirsty Duncan / Christine Jansen/ Mel Philips). 4. Contact numbers 5. General Health Care Advice in relation to transplant and immunosuppression University Hospitals Division: Islet Transplant Management. Version 04/02/2014; Dr Shareen Forbes 12

13 TABLE OF DRUGS AND TOTAL DURATION OF TREATMENT DRUG DOSE ROUTE FREQUENCY INSULIN SC OMEPRAZOLE 40mg PO OD (1000) MYCOPHENOLATE MOFETIL* 500mg or alternative dose PO BD (1000; 2200) PROGRAF (TACROLIMUS)* 0.05mg / kg PO BD (1000; 2200) Or usual dose if on drug CO-TRIMOXAZOLE 480mg PO OD (8am) for 6 months VALGANCICLOVIR 900mg (adjust dose if impaired renal function) PO OD (8am) for 6 months DALTEPARIN** 2,500 UNITS SC OD 7 days total on sc heparin *In some patients alternative immunosuppression may be appropriate ** If patient has Cr Cl<30ml/min, unfractionated heparin 5000 units SC to be prescribed IN SOME PATIENTS, THE FOLLOWING DRUGS MAY BE APPROPRIATE DRUG DOSE ROUTE FREQUENCY ISONIAZID TB PROPHYLAXIS PYRIDOXINE PROPHYLAXIS OF ISONIAZID INDUCED NEUROPATHY 300 mg PO OD 3 months 10 mg PO OD 3 months University Hospitals Division: Islet Transplant Management. Version 04/02/2014; Dr Shareen Forbes 13

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